Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set

About This 510(k) Submission

K182146 is an FDA 510(k) clearance for the Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Sol-Millennium Medical, Inc. (Lawrenceville, US). The FDA issued a Cleared decision on December 3, 2018, 117 days after receiving the submission on August 8, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.